PumpKIN PreClinical

婴儿大小的Jarvik 2000心脏是NIH儿科VAD计划开发的最小的永久植入式血泵，据我们所知，也是世界上最小的。它直径只有10.5 mm，长5.2厘米，体积4cc，足够小，可以植入3.5公斤的脑室尖部。然而，它的流量超过3L/分钟-足以容纳25公斤以下的儿童。动物植入表明，该泵保持无血栓，并在低功率下运行，不会导致溶血。该泵是一个完整的设计，包含了长期植入的所有要求，包括电机定子和转子磁铁的焊接密封，电源电缆的微型密封馈通，超长寿命陶瓷圆锥轴承设计，以及从外部控制器到植入血泵的起搏器型高弯曲寿命电力电缆。一个先进的基于微处理器的控制系统刚刚完成，尽管目前只有基本功能(速度设置、测量速度、电池剩余时间、电源、通过薄膜开关进行显示功能管理)的软件可用。这允许基本操作，但尚未实现未来计划的一些更高级的功能。 Jarvik心脏公司是一家只有36名员工的小公司，但已经成功地对成人模型Jarvik 2000进行了临床试验，在欧洲获得了CE标志批准，完成了63名患者的IDE先导性研究，并在IDE枢纽桥的150名患者中招募了100名进行移植研究。因此，该公司有足够的经验赞助婴儿Jarvik 2000的IDE临床试验，并获得HUD认证和HDE批准。在目前的五年合同期间，我们已经成功地与格里菲斯博士在马里兰大学的动物实验室进行了合作，如果我们的提案得到资助，他们将成为主要的分包商。Bartley Griffith博士与Jarvik博士共同担任心脏外科医生，在各种机械循环支持设备方面拥有丰富的心脏外科经验，既是一名儿科心脏外科医生，也是一名成人外科医生。我们已经与主要的儿科心脏外科中心建立了关系，这些中心表示有兴趣加入一项评估儿科Jarvik2000的多中心临床试验。他们包括：William Gaynor博士(宾夕法尼亚大学)、Pedro del Nido博士(波士顿儿童医院)、Richard Jonas博士(华盛顿国家儿科中心)、Ed Bovie博士(密歇根大学)、Marcelo Cardarelli博士、Duke Cameron博士和Luca Vricella博士(马里兰大学和约翰霍普金斯大学)。每个站点的PI将组成一个开发IDE应用程序的咨询小组，并将就手术技术和患者管理等其他临床问题向我们提供建议。

The infant size Jarvik 2000 heart is the smallest permanently implantable blood pump developed as part of the NIH Pediatric VAD Program, and to our knowledge, the smallest in the world. At only 10.5mm diameter, 5.2 cm long and 4cc in volume it is small enough to implant in the ventricular apex of 3.5 Kg. newborns yet it has flow capacity over 3L/min - sufficient output for children up to 25 Kg. Animal implants have shown that the pump remains free of thrombus and operates at low power without causing hemolysis. The pump represents a completed design, incorporating all of the requirements for a long term implant, including welded hermetic sealing of the motor stator and rotor magnet, miniature hermetic feed-throughs for the power cables, a very long life ceramic conical bearing design, and pacemaker type high flex life power cables from the external controller to the implanted blood pump. An advanced microprocessor based control system has just been completed, although only the software for the basic functions (speed setting, measured speed, battery remaining, power, display function management via membrane switches) is presently available. This permits basic operation but does not yet implement some of the more advanced functions planned for the future. Jarvik Heart, Inc. is a small company of only 36 employees, but has successfully conducted clinical trials with the adult model Jarvik 2000, has received CE mark approval in Europe, has completed a 63 patient Pilot IDE study, and enrolled 100 of 150 patients in the IDE pivotal bridge to transplant study. The company thus has sufficient experience to sponsor an IDE clinical trial of the infant Jarvik 2000 and to obtain HUD designation and HDE approval. Over the course of the present five year contract we have collaborated successfully with Dr. Griffith's animal laboratory at the University of Maryland, and they will be a major subcontractor if our proposal is funded. Dr. Bartley Griffith, the Co-PI together with Dr. Jarvik, has extensive cardiac surgical experience with numerous mechanical circulatory support devices, and is a pediatric cardiac surgeon as well as an adult surgeon. We have established relationships with major pediatric cardiac surgical centers that have expressed interest in joining an multi-center Clinical Trial to evaluate the pediatric Jarvik2000. These include Dr. William Gaynor (University of Pennsylvania), Dr. Pedro del Nido (Boston Children's Hospital), Dr. Richard Jonas (Washington National Pediatric Center), Dr. Ed Bovie (University of Michigan) and Dr. Marcelo Cardarelli, Dr. Duke Cameron, and Dr. Luca Vricella (University of Maryland & Johns Hopkins). The PIs from each site will comprise an advisory group for the development of our IDE application, and will advise us concerning other clinical matters including surgical technique and patient management.